MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number	383518
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when placing the bd nexiva¿ closed iv catheter system - single port the catheter was discovered to have holes and blood leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: when placing nexiva the customer has blood leaking out of the catheter with visible holes.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that when placing the bd nexiva¿ closed iv catheter system - single port the catheter was discovered to have holes and blood leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: when placing nexiva the customer has blood leaking out of the catheter with visible holes.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 31-jul-2023.H6: investigation summary: bd received a 20 gauge nexiva catheter assembly from lot 2300204 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed that the catheter assembly had some physical damage and appeared to be deformed leaving a hole in the unit.The engineer identified that this deformation likely caused the reported leakage.Therefore, based off the visual inspection the engineer was able to verify the reported defect.It was determined that this was a manufacturing defect that occurred during the assembly process.H3 other text : see h10.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - SINGLE PORT
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17435801
• Report Number: 1710034-2023-00853
• Device Sequence Number: 15674774
• Product Code: FOZ
• UDI-Device Identifier: 00382903835188
• UDI-Public: (01)00382903835188
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 383518
• Device Lot Number: 2300204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown